Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)

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Handling Out-of-Specification Results: FDA's guidance for the industry
2
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12
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10,802
v9991
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Should the Line Clearance include Machine Setup for current Operation?
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3
Views
3,632
JaxQC
C
Software Program Development GAMP Requirements
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1
Views
1,817
sagai
C
FDA Position about Stainless Steel & Ra?
2
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17
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22,847
v9991
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How to respond to a Regulator regarding missed corrective action timelines
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6
Views
2,655
v9991
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Expiry Date for Medicines and Foods
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3
Views
2,088
v9991
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Drug Products - Packaging and Labeling Operations Requirements - 211.130
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1
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2,836
tamale
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Consumables Certificates Classifications
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3
Views
1,929
Lugog
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What are the differences between US and EU Pharmacopeias?
2
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11
Views
5,197
Ajit Basrur
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"GMP Area" - FDA definition
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3
Views
7,016
lameehan
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Monograph of Fusidic acid (EP 7.3)
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3
Views
4,015
Ajit Basrur
bio_subbu
CDSCO issues Draft Guidelines for Approval of Clinical Trial & New Drugs
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0
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1,990
bio_subbu
bio_subbu
CDSCO issues Guidance Document for Import & Registration of APIs, and Formulations
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0
Views
2,447
bio_subbu
Ajit Basrur
ICH Q11 is available for comments
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0
Views
1,661
Ajit Basrur
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Out of Trend (OOT) investigation
Replies
8
Views
14,172
Ajit Basrur
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